A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Cholangiocarcinoma
- Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Pilot non- randomized safety studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Group 1 unresectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not t...
Group 1 unresectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement. Group 2 resectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement. Group 3 unresectable cholangiocarcinoma - Patients will receive Gemcitabine (800 mg/m2 IV over 30 minutes) and Oxaliplatin (85 mg/ m2 IV over 120 minutes) or Gemcitabine (1000 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement.
Tracking Information
- NCT #
- NCT04668976
- Collaborators
- Virginia Mason Hospital/Medical Center
- Investigators
- Principal Investigator: Hagen Kennecke, MD Virginia mason medical Center
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